The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Brest

About this trial

The goal of this clinical trial is to demonstrate that simulation training for paramedical staff in neurosurgery departments, in announcing and accompanying patients with a brain tumor, improves patient satisfaction when a (potentially malignant) brain tumor is discovered, compared with usual care.

The main question it aims to answer is:

\- Are patients more satisfied (as measured by scores on the EORCT IN-PATSAT32 questionnaire) with their neurosurgical hospitalization following the discovery of a brain tumor in centers where paramedics have been trained by simulation?

Researchers will compare the results of the EORTC IN-PATSAT32 questionnaire to determine whether paramedic training improves patient satisfaction between simulation-trained and untrained centers.

Participants will be asked to complete the EORT IN-PATSAT32 questionnaire at the end of their hospital stay.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient over 18 years of age

Patient covered by a social security scheme

Patient signed informed consent form

Patient found to have a brain tumor (potentially malignant, primary or secondary if this is the mode of entry into the disease)

Disqualifiers

Patients with a personal history of cancer

Patient without family AND unable to receive information

Trial design

Design model

Parallel

Treatments tested in this trial

  • Paramedic training

    Other intervention

    Nurses and care assistants at the centers randomized to the "with training" arm will undergo a day-and-a-half of training to help them support patients diagnosed with brain tumors. Training consists of half a day of theory, followed by a day of simulation.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Standard of careNo intervention 0 interventions
Group B: Paramedic trainingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measuring patient satisfaction following the discovery of a brain tumor.

Measurement of patient satisfaction following the discovery of a brain tumor via scores obtained, at the end of their neurosurgical hospitalization, in response to the EORCT IN-PATSAT32 (European Organisation of Research and Treatment of Cancer IN PATient SATisfaction 32) questionnaire, whose dimensions of interest are ordered as follows for hierarchical analysis: 1. SATNIS = nurses interpersonal skills 2. SATNIP = nurses information provision 3. SATNAV = nurses availability 4. SATNTS = nurses technical skills, 5. SATGEN = overall quality rating All of the scales and single-item measures range in score from 0 to 100. A high score represents a high level of satisfaction with care.

Time frame
The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)

Secondary outcomes

1

Measurement of patients' experiences following the discovery of a brain tumor via scores obtained (other questionnaire items)

Measurement of patients' experiences following the discovery of a brain tumor via the scores obtained at the end of their neurosurgical hospitalization in response to the other items of the EORTC IN-PATSAT32 questionnaire (European Organisation of Research and Treatment of Cancer IN PATient SATisfaction 32) : * SATEXE = exchange of information between caregivers, * SATDIS = doctors interpersonal skills, * SATDIP = doctors information provision, * SATDAV = doctors availability, * SATDTS = doctors technical skills, * SATOTH = other personal interpersonal skills, All of the scales and single-item measures range in score from 0 to 100. A high score represents a high level of satisfaction with care.

Time frame
The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)
2

Measuring patients' feelings

Measuring patients' feelings with the INCA (French National Cancer Institute) questionnaire (Sick people - Survey on the announcement of the diagnosis and the feelings of sick people) at the end of their neurosurgical hospital hospitalization.

Time frame
The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)
3

Measuring Caregivers' Experiences/Quality of Life at Work

Measurement of caregivers' experience/quality of life at work at D0 and 6 months, using the Delmas et al. questionnaire.

Time frame
Day 0 and Month 6
4

Measurement of caregivers' listening skills.

Measurement of caregivers' listening attitude, using the Porter et al. questionnaire at D0, after training and 6 months.

Time frame
Day 0, after training and Month 6

Other outcomes

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